Federal Act
on Medicinal Products and Medical Devices
(Therapeutic Products Act, TPA)


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Art. 9b Temporary authorisation for use and limited placing on the market 42

1 The Agency may tem­por­ar­ily au­thor­ise the use of medi­cin­al products re­ferred to in Art­icle 9 para­graph 2 let­ter d on cer­tain per­sons or on cer­tain cat­egor­ies of per­sons out­side clin­ic­al tri­als.

2 It may also au­thor­ise the tem­por­ary or quant­it­at­ive mar­ket­ing of a medi­cin­al product to bridge the tem­por­ary un­avail­ab­il­ity of an identic­al medi­cin­al product au­thor­ised in Switzer­land, provided that:

a.
the medi­cin­al product is au­thor­ised in an­oth­er coun­try that has equi­val­ent medi­cin­al product con­trol; and
b.
no es­sen­tially identic­al medi­cin­al product is au­thor­ised and avail­able in Switzer­land.

42 In­ser­ted by No I of the FA of 18 March 2016, in force since 1 Jan. 2019 (AS 2017 2745, 2018 3575; BBl 2013 1).

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